DBKS Life Sciences delivers specialized pharmaceutical formulation development, analytical method validation, bioequivalence support, EU & US eCTD filings, finished dosage commercial supply, and green/brownfield turnkey facility design.
Core Competencies
End-to-end scientific and engineering capabilities spanning formulation, analytical validation, regulatory submissions, commercial finished dosage supply, and turnkey cGMP manufacturing facility design.
Comprehensive formulation design grounded in Quality by Design (QbD) principles for novel generics, life cycle extensions, and challenging molecules across multiple dosage forms.
Development, optimization, and rigorous validation of sensitive, reproducible, and stability-indicating analytical procedures adhering strictly to ICH Q2(R1/R2) guidelines.
End-to-end Bioequivalence study management, CRO auditing, clinical protocol formulation, dissolution profile matching, and regulatory pharmacokinetic evaluation.
Scientific troubleshooting, reformulation, and process optimization for existing commercial products facing batch failures, stability deviations, or regulatory non-compliance.
Comprehensive global regulatory affairs consultancy, dossier authoring, gap analysis, and electronic publishing for US FDA ANDAs and European Union MAA procedures.
Reliable commercial-scale contract manufacturing and supply across multiple dosage forms, compliant with WHO-GMP, US-FDA, and EU-GMP cGMP standards.
Complete turnkey engineering for new greenfield manufacturing plants and brownfield modernization: conceptual design, cGMP cleanrooms, HVAC, water systems, qualification, and successful regulatory inspection clearance.
Connect directly with our technical and business development team to discuss your formulation development, regulatory filings, commercial supply, or turnkey facility projects.
All discussions and technical data exchanges are safeguarded under standard non-disclosure agreements (NDA).
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